(150 days)
The vPatch is indicated for management of premature ejaculation in males who ejaculate after intromission. It is designed to increase the time between arousal and ejaculation by delivery of short duration, low-intensity electrical stimulation to the perineal muscles and nerves during intercourse.
The vPATCH is a single-use disposable patch designed to manage premature ejaculation. It contains electrodes that deliver electrical muscle stimulation (EMS) to the perineal muscles during intercourse to help the user postpone ejaculation. The patch works by delivering shortduration, low-intensity EMS to the perineal muscles and nerves during intercourse. The stimulation contracts the pelvic floor muscles, which consequently delays rhythmic contractions of ejaculation. This increases the time between arousal and ejaculation. The vPATCH is comprised of several layers which include the cover, electrical circuit board including batteries, and adhesive electrodes. The skin-contacting materials are hydrogel, polyolefin foam, and thermoplastic elastomer (TPE). The vPATCH is available in two intensity levels (High and Low).
The provided text describes a 510(k) submission for the vPATCH device, which manages premature ejaculation, to expand its indication from prescription use (Rx) to over-the-counter (OTC) use. The key study supporting this expansion is a Human Factors (HF) validation study that included label comprehension and self-selection components.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria for the vPATCH relate primarily to demonstrating its safety and effectiveness for OTC use, specifically that users can understand how to use it safely and effectively without a healthcare professional's guidance. The core performance is derived from the Human Factors study.
| Acceptance Criterion (Implicit) | Reported Device Performance and Study Findings |
|---|---|
| Label Comprehension: Intended users can correctly understand the instructions for use (IFU) and labeling without healthcare professional guidance. This includes understanding the indications, contraindications, warnings, and how to use the device. | The human factors validation study included a label comprehension study. The results supported the expanded indication, demonstrating that the intended user population is able to correctly identify themselves as intended users and correctly use the device. While specific quantitative metrics (e.g., % correct responses) are not provided in this summary, the conclusion states that the study demonstrates users "are able to correctly identify themselves as intended users as well as correctly use the device without the need for guidance or intervention of a healthcare professional." |
| Self-Selection: Users can correctly identify whether the device is appropriate for them based on the labeling, including recognizing if they are an intended user, not intended user, or contraindicated user. | The human factors validation study included a self-selection study. The study was completed using representative users from three groups: Indicated, Not Indicated, and Contraindicated. The results supported the expanded indication, demonstrating that the intended user population is able to correctly identify themselves as intended users. |
| Usability (Safe & Effective Use without Professional Intervention): Users can safely and effectively perform the tasks necessary to use the vPATCH as intended in a real-world (simulated) environment without errors that could lead to harm or ineffective treatment. | The human factors validation study was conducted in a simulated-use format. Participants had access to the patch, IFU, and accessories. The study's purpose was to identify root causes of difficulties or use errors. The conclusion states, "The vPATCH has been found to be safe and effective for the intended users, uses, and use environments," and that users can "correctly use the device without the need for guidance or intervention of a healthcare professional." A supplemental study was conducted for a minor design change to further improve usability. |
| Biocompatibility: The device materials in contact with the body are biocompatible and do not cause adverse reactions (cytotoxicity, sensitization, irritation). (This is a general safety criterion for the device itself, reinforced due to minor device differences, and implicitly part of "safe and effective.") | Biocompatibility tests were repeated: Cytotoxicity, Sensitization, and Irritation. These were performed in accordance with FDA Guidance ISO 10993-1. The successful completion of these tests (implied by the submission's conclusion of safety and effectiveness) means the materials meet acceptance criteria for biological safety. |
| Non-Clinical Performance (Device Functionality and Integrity): The device functions as intended over its shelf-life and in various specified conditions (e.g., dimensional integrity, bonding strength, liquid ingress protection, power performance). (Again, a general safety/effectiveness criterion for the device itself, not specific to OTC.) | Non-clinical performance tests were performed: Shelf-Life testing (packaging integrity and functionality), Dimensional validation (critical measurements), Cover bonding strength, Liquid ingress protection, and Power performance. The successful completion of these tests (implied by the submission's conclusion of safety and effectiveness) means the device meets acceptance criteria for its physical and electrical performance. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for the Test Set: Not explicitly stated in the provided text. The text only mentions "representative users of the vPATCH from three (3) groups (Indicated, Not Indicated, Contraindicated)."
- Data Provenance: Not explicitly stated in the provided text. It is implied to be prospective, as it describes a study conducted for the submission. The country of origin for the data is also not explicitly stated, though the applicant's address is Israel and the regulatory consultant is in the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not provided in the text. For a Human Factors study, "experts" typically establish the study design and analysis, rather than the ground truth of a medical condition itself. The "ground truth" in this context would be the correct performance of tasks and understanding of information, as defined by the device's intended use and labeling. The text mentions "analyzed to identify root causes of any difficulties or use errors observed during testing," implying a standard HF evaluation process.
4. Adjudication Method for the Test Set
- This information is not provided in the text. For Human Factors studies, adjudication often involves observation and structured debriefing rather than traditional "reader" adjudication. Errors or difficulties are recorded and categorized, then analyzed by the HF team.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This type of study is pertinent for diagnostic AI devices where human readers (e.g., radiologists) interpret images with or without AI assistance. The vPATCH is a direct-to-consumer electrical stimulation device, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable directly. The vPATCH is an active medical device, not an AI algorithm. Its performance is intrinsically tied to human use. However, the "non-clinical performance testing" and "biocompatibility testing" can be considered analogous to "standalone" testing in that they evaluate the device itself (components, electrical performance, materials) independent of a human user's interaction beyond applying the patch.
7. The Type of Ground Truth Used
- For the Human Factors study (label comprehension and self-selection), the "ground truth" was defined by the device's intended use, labeling (Instructions for Use - IFU), and the design of the tasks. For example, the ground truth for a comprehension question would be the correct answer as stated in the IFU/labeling. For a self-selection task, the ground truth would be whether the participant accurately categorized themselves (e.g., "indicated user" if they met the criteria, "contraindicated" if they had a contraindication).
- For the biocompatibility and non-clinical performance tests, the "ground truth" was established by recognized international standards (e.g., ISO 10993-1) and internal design specifications of the device.
8. The Sample Size for the Training Set
- Not applicable. The vPATCH is not an AI/machine learning device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no training set for this type of device.
§ 876.5026 Non-implanted electrical stimulation device for management of premature ejaculation.
(a)
Identification. A non-implanted electrical stimulation device for management of premature ejaculation is intended to be used in patients with premature ejaculation by delivery of electrical stimulation to the perineal muscles and nerves.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device.
(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Mechanical performance;
(ii) Electrical stimulation parameters; and
(iii) Battery performance.
(4) Performance testing must support shelf life by demonstrating continued device functionality over the identified shelf life.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Labeling must include:
(i) Specific instructions regarding safe placement and correct use of the device;
(ii) Warning(s) against use by patients with active implanted medical devices; and
(iii) A shelf life.